The Company – Syner-G Pharma Consulting, LLC:

  • A young, dynamic, entrepreneurial, and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing and Controls (CMC) for biopharmaceutical companies (small molecule and biologic products)
  • Adept in developing risk-based CMC strategies following cGMP for 21st Century initiatives and Quality by Design (QbD) principles
  • Distinguish ourselves by our passion for creativity and innovation
  • Offer flexible work environment allows for on-site, off-site, and virtual-office scenarios
  • Clients include national and multinational pharmaceutical companies

The Candidate:

Syner-G Pharma, CMC Consulting is seeking an exceptional science professional to join our Regulatory Affairs team. The candidate will be responsible for supporting our Biotechnology/Pharmaceutical clients throughout the regulatory filing process, including serving as the client lead as Senior Manager of Regulatory Affairs. A successful candidate will have a proven track record of learning and applying scientific principles to solve CMC technical and project management challenges. Seeking a passion to help patients by enabling the expeditious development and approval of high-quality, life-saving medicines.

Required Activities/Experience:

  • MS in Chemistry, Biology, Chemical Engineering, Pharmacy, Healthcare, Public Health, or a related field.
  • 7+ years’ experience in the Authoring and review of CMC sections for NDA, BLA, IND, and IMPD
  • Creation and authoring of global and regional dossiers (IND, IMPD, and Canadian QOS).
  • Coordinate timely & accurate assembly of responses to inquiries from the FDA on CMC content
  • Strategize regulatory CMC pathway for new small & large molecules
  • Assess and strategize post-approval changes and relevant submission
  • Authoring CMC amendments, supplements, and annual reports
  • Preparing briefing documents for the health authority meetings
  • Regulatory agency meeting support including meeting preparation and briefing document creation.
  • Review of analytical test methods, specifications, and stability protocol/report/data
  • Support and prepare other CMC ad-hoc requests at the pre & post-approval stage of the product
  • Coordinate timely & accurate assembly of responses to inquiries from the FDA on CMC content
  • Sponsor consultancy regarding drug development including timeline management

Critical success factors:

  • Ability to work with diverse stakeholders, both internally and at commercial contract manufacturers.
  • Strong knowledge and demonstrated practice of cGMP.
  • Detail-oriented with strong written and oral communication skills and proven history of working with others in a multidisciplinary team environment.
  • Ability to troubleshoot problems, work within a team, and independently design, develop, and execute experiments.
  • Ability to manage several projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.
Job Category: Manager
Job Type: Full Time